HIV Treatment Update. Anton Pozniak Consultant Physician, Director of HIV Services Chelsea and Westminster Hospital, London

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1 HIV Treatment Update Anton Pozniak Consultant Physician, Director of HIV Services Chelsea and Westminster Hospital, London

2 Guidelines Nuke sparing Nukes Efavirenz placement as the gold standard ARV Role of PIs STRs Switching Second Line

3 Choosing the best Regimen Evolution of Better Treatments DHHS panel criteria for regimen selection Preferred regimens (studied in RCTs) Optimal and durable virologic efficacy Favourable tolerability and toxicity profiles Ease of use DHHS Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. March 27, Available at:

4 Summary of key randomized clinical trials in ARV-naïve patients EFV vs. NNRTI 2NN, ECHO 1, THRIVE 2 ATV /r vs. NNRTI ACTG DRV /r vs. PI ARTEMIS 4 ACTG5257 RAL vs. NNRTI STARTMRK 5 EVG/ c vs. NNRTI QUAD102 DTG vs. NNRTI Single vs. PI ACTG ACTG vs. PI CASTle ACTG5257 vs. INI ACTG5257 vs. INI Spring vs. PI QUAD103 vs. INI Spring vs. INI STARTMRK 5 vs. INI QUAD103 vs. PI / NRTI ACTG5257 NEAT001 vs. PI Flamingo NNRTI = non-nucleoside reverse transcriptase inhibitor; PI = protease inhibitor; INI = integrase inhibitor. 1. Molina J-M, et al. Lancet 2011;478: ; 2. Cohen CJ, et al. Lancet 2011; 378: ; 3. Daar E, et al. Ann Intern Med 2011;154: ; 4. Ortiz R, et al. AIDS 2008;22: ; 5. Lennox JL, et al. Lancet 2009;374: ; 6. Riddler SA, et al. N Engl J Med 2006;358: ; 7. Molina J-M, et al. Lancet 2008;372:

5 Comparison of International Guidelines 2014 Regimen DHHS IAS EACS EFV/TDF/FTC Recommended Recommended Recommended DRV/r + TDF/FTC Recommended Recommended Recommended ATV/r + TDF/FTC Recommended Recommended Recommended RAL + TDF/FTC Recommended Recommended Recommended EVG/c+TDF/FTC Recommended Recommended Recommended DTG + ABC/3TC DTG + TDF/3TC Recommended Recommended - US Department of Health and Human Services Guidelines; Revised January 10, 2011 Available at: Thompson MA, et al. JAMA 2010;304(3): ;

6 DO WE STILL NEED NUKES? TOLERABILITY AND TOXICITY NUKES ASSOCIATED WITH CVS, RENAL AND BONE PROBLEMS

7 NRTI-sparing regimens 7 randomised trials of PI/r + RAL versus PI/r + 2NRTIs HIV RNA <50 copies/ml (switch = failure endpoint) Overall, in 7 randomised trials of 1266 patients, PI/r + raltegravir showed HIV RNA suppression rates 10% lower than PI/r + 2NRTIs (p=0.008). However there was evidence for heterogeneity between the trials (p=0.03). Favours 3-drug treatment Favours 2-drug treatment

8 If we still need Nukes We need to sort out the ABC CV question D:A:D: current abacavir use associated with 98% increase in acute MI risk Adjusted relative rate of MI in pts currently receiving ABC Overall Pre-3/08 Post-3/ ( ) 1.97 ( ) 1.97 ( ) No current ABC Events/PYs 600/295, /169, /126,225 Rate/100 PYs 0.20 ( ) 0.25 ( ) 0.14 ( ) Current ABC Events/PYs 341/71, /40,833 94/31,084 Rate/100 PYs 0.47 ( ) 0.61 ( ) 0.30 ( ) Sabin, C et al. CROI Abstract 747LB.

9 Change in BMD (%) TDF and Bone loss ACTG 5280: high-dose vitamin D and calcium attenuate bone loss in TDF patients Randomised, double-blind trial in patients initiating TDF/FTC/EFV with baseline vitamin D 10 75ng/mL Vitamin D3 4,000 IU/day plus calcium carbonate 1,000 IU/da Decline in BMD from baseline to week 48 Vitamin D/calcium P< Total hip Placebo P= Lumbar spine Lower and upper edges of box indicate 25 th and 75 th percentiles; lines inside box indicate median Overton, ET et al. CROI Abstract 133

10 IS IT TIME TO MOVE ON FROM EFAVIRENZ?

11 Why is EFV no longer so gold? Has been beaten by the integrase inhibitors Non-inferior to other STRs (Stribild and Eviplera ) But the latter have less toxicity Baseline resistance increased in MSM NNRTI resistance develops in about half of the failures The toxicity is not acceptable now? PI, important points to consider and indication are outlined at the end of this presentation

12 SINGLE Trial: DTG vs EFV in Naive Week 48 efficacy results VF: 5% ABC/3TC/DTG DC Adverse Events: 2% VF: 6% TDF/FTC/EFV600 DC Other =5% DC Adverse DC Other:3% Events: 10% HIV RNA <50 88% HIV RNA <50 81% Ref: Dolutegravir FDA prescribing information

13 HIV-1 RNA < 50 c/ml (%) STARTMRK: Efficacy of RAL vs EFV Durability. Long term side effects RAL is BID vs QD (EFV) but fewer adverse events (52% vs 80%) ITT, NC = F CD4+ gain: Pts at Risk, n RAL 400 mg BID EFV 600 mg QHS Wks Rockstroh JK, et al. J Acquir Immune Dis Syndr. 2013;63:77-85.

14 Efavirenz tolerability But do the neuropsychiatric symptoms matter? In the short-term For the majority of patients probably not In the long-term if neuropsychiatric symptoms persist Then?

15 Efavirenz tolerability Persistence of neuropsychiatric symptoms in randomised controlled trials Most EFV-associated neuropsychiatric symptoms are mild and transient, occurring during the first 2-4 weeks In some patients, neuropsychiatric symptoms can be long-lasting and may persist for up to two years after starting EFV 1,2 1. Zolopa, A et al. HIV ; Glasgow. O Gazzard, B et al. AIDS 2011;25:

16 Probability Risk of suicidality increased in patients treated with EFV-containing regimens Treatment with EFV is associated with increased risk of suicidality Absolute risk is small EFV EFV-free Risk of attempted or completed suicide also associated with EFV HR: 2.58; 95% CI: 0.94 to 7.06; P=0.06 EFV is also associated with increased risk of death from injury, substance use or unknown causes Careful attention should be paid to cause of death in all clinical trials HR: events/5817 (95% CI ; P =.006) PY (8.08/1000 PY) Multivariate analysis of factors associated with suicidality in ACTG clinical trials Variable HR (95% CI) P value Randomly assigned EFV 2.15 ( ) events/4099 PY (3.66/1000 PY) Weeks to suicidality 192 Age category, yrs < ( ) 1.69 ( ) 1.00 (reference) 0.04 Hx IDU 2.18 ( ) 0.02 Psychiatric hx or psychoactive rx 3.90 ( ) <0.001 Mollan, K et al. IDWeek Abstract 40032

17 Using Real World Data to Assess the Risk of Suicidality among Patients Initiating an Efavirenz versus an Efavirenz-Free Antiretroviral Regimen.Nkhoma E et al IDWeek October 8-12, 2014, Philadelphia. Abstract 818

18 Dose Reduction of EFV ENCORE1: 400-mg EFV non-inferior to 600-mg EFV With TDF/FTC for Initial ART Randomized, double-blind, placebo-controlled, non-inferiority phase III trial Part of ongoing effort to identify ARVs effective at lower doses (and cost) Stratified by clinical site and HIV-1 RNA at screening (< 100,000 or 100,000 copies/ml) Week 48 HIV-1 RNA < 200 c/ml at Week 48 (%) NC=F ART-naive pts, CD cells/mm 3, HIV-1 RNA > 1000 copies/ml (n=636) EFV 400 mg + placebo + TDF/FTC 300/200 mg (n = 324) EFV 600 mg + TDF/FTC 300/200 mg (n = 312) No significant difference in SAEs between treatment arms More pts with study drug-related AEs for EFV 600 mg vs EFV 400 mg (47.2% vs 36.8%; p=0.008) More pts discontinued EFV 600 mg due to AE vs EFV 400 mg (1.9% vs 5.8%; p=0.010) *EFV administered as 200-mg tablets. Puls, R et al. IAS Abstract WELBB01

19 Starting another NNRTI STaR Study Multicenter, international, randomized, open-label, Phase 3b, 96-week study ARV-naive HIV-1 RNA 2500 c/ml Sensitivity to EFV, FTC, RPV, TDF (N=786) Stratified by HIV RNA ( or >100,000 c/ml) n=394 n=392 RPV/FTC/TDF STR EFV/FTC/TDF STR 48 Weeks Primary Endpoint 96 Weeks Primary endpoint: Secondary endpoints: Efficacy of the 2 STRs by proportion with HIV-1 RNA <50 c/ml at Week 48 (Snapshot analysis); non-inferiority margin of 12% Safety and efficacy of the 2 STRs by proportion with HIV-1 RNA <50 c/ml at Week 96 (Snapshot analysis) Change in CD4 cell count at Weeks 48 and 96 Genotype/phenotype resistance at time of virologic failure

20 % of Subjects STaR Virologic Outcomes by Snapshot Analysis and CD4 Change at Weeks 48 & 96 Virologic Outcomes Virologic Success RPV/FTC/TDF W48 RPV/FTC/TDF W EFV/FTC/TDF W48 EFV/FTC/TDF W96 13 W48 W96 W48 W96 W48 W Virologic Failure No Data in Window Favours EFV/FTC/TDF W48 W96 Favours RPV/FTC/TDF % 0 12% Mean CD4 count change (cells/mm 3 ) Week 48: RPV/FTC/TDF +200 vs. EFV/FTC/TDF +191 (p=0.37) Week 96: RPV/FTC/TDF +278 vs. EFV/FTC/TDF +259 (p=0.17)

21 STaR All Grades Treatment-Emergent Adverse Events of Importance* through Week 96 Events >5% of subjects RPV/FTC/TDF n=394 EFV/FTC/TDF n=392 Nervous System Events, n (%) 107 (27%) 186 (47%) p< Dizziness 27 (7%) 90 (23%) Headache 56 (14%) 62 (16%) Somnolence 10 (3%) 30 (8%) Psychiatric Events, n (%) 111 (28%) 192 (49%) p< Abnormal Dreams 23 (6%) 101 (26%) Anxiety 28 (7%) 37 (9%) Depression 36 (9%) 47 (12%) Insomnia 45 (11%) 59 (15%) Rash Events, overall, n (%) 62 (16%) 95 (24%) p=0.003 Rash 31 (8%) 52 (13%) *Prespecified evaluation for common adverse events included in the US Prescribing Information and EMA SmPC for efavirenz, rilpivirine, COMPLERA/EVIPLERA and ATRIPLA One suicide occurred in the EFV/FTC/TDF arm, Day 36 of study

22 Role for PI/r as first line therapy

23 ACTG 5257: Study Design HIV-infected patients, 18 yr, with no previous ART, VL 1,000 c/ml at U.S. Sites (N=1,809) Randomized 1:1:1 to Open Label Therapy Stratified by screening HIV-1 RNA level ( vs. <100,000 c/ml), A5260s metabolic substudy participation, cardiovascular risk ATV 300 mg QD + RTV 100 mg QD + FTC/TDF 200/300 mg QD (N=605) RAL 400 mg BID + FTC/TDF 200/300 mg QD (N=603) DRV 800 mg QD + RTV 100 mg QD + FTC/TDF 200/300 mg QD (N=601) Primary Endpoints* Time to HIV-1 RNA >1000 c/ml wk 16 to before wk 24, or >200 c/ml at or after wk 24 (VF) Time to discontinuation of randomized component for toxicity (TF) Pre-planned Composite Endpoint The earlier occurrence of either VF or TF in a given participant Landovitz L, et al. 21st CROI; Boston, MA; March 3-6, Abst. 85.

24 Proportion VL 50 copies/ml ITT, regardless of ART change ITT, off-art=failure (SNAPSHOT) ATV/r 83% 90% 88% 90% RAL 90% 92% 94% 94% DRV/r 83% 88% 89% 90% ATV/r 70% 73% 63% 62% RAL 84% 83% 80% 76% DRV/r 77% 77% 73% 71%

25 ACTG 5257: Toxicity Associated Discontinuation ATV/r (N=605) RAL (N=603) DRV/r (N=601) Any Toxicity Discontinuation 95 (16%) 8 (1%) 32 (5%) Gastrointestinal Toxicity Jaundice/Hyperbilirubinemia Other Hepatic Toxicity Skin Toxicity Metabolic Toxicity Renal Toxicity (All Nephrolithiasis) Abnormal Chem/Heme (Excl. LFTs) Other Toxicity Landovitz L, et al. 21st CROI; Boston, MA; March 3-6, Abst. 85.

26 Resistance to Study Agents None to boosted PIs 1809 Participants ATV/r 75/94 VF Available 9 Any Resistance (1.5%) 295 Virologic Failures RAL 65/85 VF Available 18 Any Resistance (3%) 1 Baseline Missing 56 VF Failed to Amplify DRV/r 99/115 VF Available 4 Any Resistance (<1%) 2 TDF 0 TDF 0 TDF 5 FTC 7 FTC 3 FTC 1 TDF+FTC 1 RAL 0 RAL+FTC 0 RAL+FTC+TDF 0 TDF+FTC 1 RAL 7 RAL+FTC 3 RAL+FTC+TDF 0 TDF+FTC 1 RAL 0 RAL+FTC 0 RAL+FTC+TDF

27 Which Patient for Boosted PIs? Considerations in Favor Effective across HIV-1 RNA, CD4+ strata [1,2] Few CNS adverse events [1,2] Little/no emergence of resistance at VF [1,2] Preferred agents in pregnancy 3 Low risk for new resistance to develop in those with transmitted resistance or those with poor adherence Considerations Against No coformulations with NRTIs (yet) Variable lipid effects [1,2] Concerns about renal function (greatest concern when ATV/RTV combined with TDF) [1,4] Drug drug interactions with other drugs metabolized by CYP system [5,6] Hyperbilirubinemia with ATV [1,5] 1. Molina JM, et al. Lancet. 2008;372: Ortiz R, et al. AIDS. 2008;22: DHHS Perinatal Guidelines. July Mocroft A, et al. AIDS. 2010;24: Atazanavir [package insert]. 6. Darunavir [package insert].

28 The single pill? Many regimens are single tablet currently all with 3TC/FTC in backbone Eviplera RPV/FTC/TDF Triumeq DTG/ABC/3TC Stribild Elvitegravir/cobicistat/FTC/TDF Atripla EFV/FTC/TDF PI, important points to consider and indication are outlined at the end of this presentation

29 More STRs on the Way! 29

30 30

31 31

32 FDCs/STRs-issues not for everyone Cannot adjust the doses Important in renal disease and with DDIs Some may be too big to make Co-packaging vs single pill Does differing half lives matter if you stop? All have FTC/3TC at present STR cross resistance 184V is a multidrug resistant mutation to all current and proposed STR! Where is the data re significant difference Patented so more expensive

33 What about Switches Due to Toxicity 923 regimens switched over 18 months affecting 12% (n=722/6211) Predicted annual switch rate of 8% Half switches for toxicity 8% 9% 18% 27% CNS SE GI CVD Risk 14% Hepatotoxicity 12% Metabolic 12% Renal Toxicity Other Boyle A et al, HIV , Oral 312.

34 Many switch options if undetectable Need a reason to switch! Must check treatment history and prior resistance tests Recent trials PI/r to rilpivirine plus TDF/ FTC PI/r to Stribild NNRTI to Stribild

35 SECOND-LINE TREATMENT SWITCH FOR VIROLOGICAL FAILURE

36 HIV-1 RNA < 200 c/ml (%) SECOND-LINE: Noninferiority of LPV/RTV + RAL vs LPV/RTV + NRTIs in Pts With First-Line VF P = LPV/RTV + RAL LPV/RTV NRTIs Wk Humphries A, et al. CROI Abstract 180LB. Graphic used with permission.

37 EARNEST: Second-line LPV/RTV-Based ART After Initial NNRTI Failure Clinical Outcomes at Wk 96 Patients (%) PI/NRTI PI/RAL PI mono Good Disease Control* HIV-1 RNA < 400 copies/ml HIV-1 RNA < 50 copies/ml * Good disease control at Wk 96 defined as pt alive, no new WHO4 events from Wks 0-96, and CD4+ cell count > 250 cells/mm 3, and HIV-1 RNA < 10,000 copies/ml or > 10,000 copies/ml without PI resistance mutations. Paton N, et al. IAS Abstract WELBB02.

38 Conclusion Modern HAART is highly effective but... Need to maintain lifelong well tolerated therapy is Efavirenz going to remain first line treatment of choice What will be the role of PI/r and integrase? STRs are becoming a standard of care in Naives Switching because of toxicity is common Second Line therapy can you move to a second regimen without resistance testing 38

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